LISA D. HAMILTON-FIELDMAN, Special Master.
This is an action by Emily Culligan ("Petitioner") seeking an award under the National Vaccine Injury Compensation Program (hereinafter "Program").
Petitioner was born on June 27, 1984. Pet'r's Ex. 1, ECF No. 7-2. It is unclear when she experienced menarche,
Petitioner briefly used various forms of hormonal contraception, including the NuvaRing, but did not want to use hormones for any length of time "on general principals [sic]." Pet'r's Ex. 5 at 1, ECF No. 7-6. She had a non-hormonal copper Paragard IUD implanted on November 15, 2006, Pet'r's Ex. 6 at 5-6, ECF No. 7-7, which remained in place until she had it removed in February of 2013, Pet'r's Ex. 2 at 8, ECF No. 7-3. She had a history of cystic acne, for which she was prescribed Spironolactone in early 2011, but no history of hirsutism. Id. at 17.
On March 31, 2010, Petitioner saw Laila Sillay, M.D., her gynecologist, for a routine annual examination. Id. at 21-23. She reported menstrual cycles that occurred every 25 days and lasted for 5 days. Id. at 21. She received her first dose of the HPV vaccine. Id. at 22. She received the second dose of the vaccine on June 1, 2010. Id. at 20. On October 4, 2010, she was administered the third dose of the HPV vaccine, and she received a seasonal flu vaccine. Id. at 19.
Petitioner returned to Dr. Sillay on May 10, 2011, again for a routine examination. Id. at 17-18. Her last reported menstrual period was almost three months prior, February 21, 2011, and she reported a six-month history of less frequent, heavier, and longer (7-10 days) menstrual periods. Id. at 17. The assessment was oligomenorrhea
Petitioner next saw Dr. Sillay on January 15, 2013. Id. at 11-13. She reported that her last menstrual period was August 22, 2012, and that she had regular cycles until two years earlier when she developed oligomenorrhea. Id. at 11. She had been given Provera in May 2011, which resulted in withdrawal bleeding. Id. The assessment was oligomenorrhea, mild acne, and questionable PCOS. Id. at 12. She was given another progestin challenge. Id.
On February 28, 2013, petitioner saw Dr. Sillay for IUD removal and evaluation of amenorrhea. Id. at 8-9. She related a recent history of oligomenorrhea, with cycles every two to three months, and amenorrhea since her wedding in August 2012. Id. at 8. She had not responded to the Provera. See id. Her IUD was removed, and labs were drawn. Id. at 8. A note dated March 4, 2013, indicates that the labs showed elevated FSH and low E2 and progesterone. Id. at 7. She was to repeat the labs; if her FSH was still elevated, she would be referred to a reproductive endocrinologist for Primary Ovarian Insufficiency ("POI"). Id.
Petitioner returned to Dr. Sillay on March 14, 2013 for the repeat labs. Id. at 6. On March 18, 2013, Dr. Sillay made a note that repeat labs had shown "persistently elevated" FSH and low E2, consistent with POI. Id. at 5.
On March 24, 2013, Petitioner consulted with Brandon J. Bankowski, M.D., at Oregon Reproductive Medicine. Pet'r's Ex. 8 at 1-4, ECF No. 17-1. He concurred with Dr. Sillay's POI diagnosis.
Petitioner underwent a pelvic ultrasound on April 19, 2013, which showed a cyst on her right ovary, and a trilaminal endometrium. Id. at 5. A repeat pelvic ultrasound on May 15, 2013, showed a homogenous endometrium. Id. at 3. A third pelvic ultrasound performed on June 6, 2013, showed a likely intraovarian cyst in the right ovary, but was otherwise normal. Pet'r's Ex. 4 at 2, ECF No. 7-5.
On April 18, 2014, Petitioner filed the present action alleging that the Human Papillomavirus vaccinations ("Gardasil" or "HPV" vaccines) administered to her on March 31, 2010, June 1, 2010, and October 4, 2010 caused her to suffer from POI. Pet., ECF No. 1. Petitioner was, and continues to be, represented by Mark Krueger of Krueger & Hernandez, S.C. Pet. at 2. The case was initially assigned to Special Master Christian Moran. Notice of Assignment, ECF No. 2.
Petitioner filed eight medical record exhibits between May 20 and July 21, 2014, see Docket Report; in the interim, the case, along with several others filed by petitioners who had alleged similar injuries caused by Gardasil, was reassigned to the undersigned. See Order Reassigning Case, ECF No. 14. Petitioner filed a statement of completion on July 30, 2014. Statement of Completion, ECF No. 19.
On August 14, 2014, Respondent filed a Rule 4(c) Report and Motion to Dismiss ("Respondent's Report"), in which she contended that Petitioner was not entitled to a Program award. Resp't's Report at 3-5, ECF No. 20. Respondent argued that the first symptom of Petitioner's POI was oligomenorrhea, which Petitioner experienced in "late 2010"; accordingly, Petitioner's claim was untimely under the Vaccine Act's statute of limitations. Id. at 4 (citing 42 U.S.C. § 300aa-16(a)(2) (2012) (requiring that vaccine-related injury petitions be filed prior to "expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset . . . of such injury")). Respondent also argued that, even if Petitioner's claim was not time-barred, Petitioner had failed to prove causation under Althen v. Sec'y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). Id. at 4-5.
At a status conference held on September 23, 2014, the undersigned discussed with the parties the necessity of establishing when the statute of limitations began to run in the instant case-and in the other cases in which Mr. Krueger had alleged that petitioners' POI had been caused by Gardasil vaccinations-in order to assess timeliness. See Scheduling Order (Sept. 25, 2014), ECF No. 22. The undersigned directed Petitioner to begin the process of identifying all of the POI petitioners so that an assessment of timeliness could take place in all of those cases. Id.
On October 1, 2014, Petitioner filed a status report in which she identified eight POI cases
A third status conference was held on November 20, 2014, during which the parties agreed that "in all pending [POI] cases . . . an expert hearing [would] be held to address the question of what constitutes `the first symptom or manifestation of [POI] onset recognized as such by the medical profession at large.'" Scheduling Order (Nov. 24, 2014) at 1, ECF No. 26 (citing Cloer v. Sec'y of HHS, 654 F.3d 1322, 1340 (Fed. Cir. 2011) (en banc)). The undersigned explained that a timeliness determination would be made on the basis of the evidence presented at the Culligan hearing; similar hearings would not be conducted in the other POI cases, all of which would trail Culligan for purposes of timeliness determinations. Id. The undersigned also added four additional POI cases
The parties and the undersigned proceeded to identify questions for the experts (to be researched and answered before the hearing) regarding the nature and timing of the first symptom or manifestation of onset of POI in the aforementioned cases. See, e.g., Order (Feb. 18, 2015) at 1, ECF No. 37; Scheduling Order (Jan. 30, 2015) at 1, ECF No. 36; Pet'r's Status Report (Dec. 29, 2014) at 1, ECF No. 31; Scheduling Order (Nov. 24, 2014) at 2; Resp't's Status Report (Oct. 28, 2014) at 1, ECF No. 24. The parties and their experts ultimately agreed that, except in Culligan, in which the entire medical record would be considered by the experts, the experts would "offer opinions regarding the onset issues in the trailing cases by considering the facts of those cases as hypotheticals." Joint Status Report (Jan. 20, 2015) at 1, ECF No. 33. To facilitate this process, Petitioner filed summaries of the facts of all twelve POI cases. See Pet'r's Ex. 9, ECF No. 34-2.
At a status conference held on January 28, 2015, the undersigned set deadlines for the parties' expert reports regarding timeliness. See Order (Jan. 30, 2015) at 2. The experts were directed to address all of the identified timeliness questions separately, "on a question-by-question basis." Id. at 1.
On February 19 and March 3, 2015, three additional cases,
On March 12, March 13, and April 29, 2015, Petitioner filed expert reports and supporting medical literature, all of which were purportedly limited to the issue of timeliness. See Pet'r's Ex. 13, ECF Nos. 47-2 to 51-6; Pet'r's Ex. 15, ECF Nos. 53-1 to 54-3; Pet'r's Ex. 17.
The undersigned convened a status conference on April 1, 2015, after having reviewed Petitioner's expert reports. See Scheduling Order (Apr. 2, 2015) at 1, ECF No. 55. The undersigned noted that, "notwithstanding the fact that Petitioner's onset experts have now reviewed the medical records associated with every [POI] case, Respondent's onset expert(s) will review only the cases' factual summaries, the Culligan record, and Respondent's list of hypothetical questions." Id. Also, having expressed some concern about the extent to which Petitioner's expert reports reflected an understanding of the relevant question regarding timeliness, the undersigned reiterated the following:
Id. (full citation omitted).
Respondent then filed an expert report regarding timeliness, as well as relevant medical literature, on May 8, May 28, and June 1, 2015. Resp't's Ex. A to A.32, ECF Nos. 57-1 to 59-6, 63-1 to 63-3, 66-1 to 67-4. Respondent's expert report was authored by Dr. David Frankfurter. Resp't's Ex. A at 6.
At a status conference held on May 14, 2015, Respondent confirmed that, in preparing his expert report, Dr. Frankfurter had reviewed only the factual summaries submitted by Petitioner (and the medical record from Culligan). See Order (May 15, 2015) at 1, ECF No. 61. Mr. Krueger agreed that, notwithstanding the fact that his experts had reviewed all of the medical records in all of the POI cases, "his experts would be referring to the factual summaries rather than to the medical records themselves" at the timeliness hearing. Id.
The parties filed their pre-hearing briefs simultaneously on June 1, 2015, see Pet'r's Prehearing Submissions, ECF No. 65; Resp't's Prehearing Submissions, ECF No. 69; and the hearing took place on June 16 and 17, 2015, see Minute Entry (June 18, 2015). Petitioner's experts, Dr. Gersh and Dr. Hamiel, and Respondent's expert, Dr. Frankfurter, testified. Tr. at 4, 255, ECF Nos. 81, 83.
On July 1, 2015, the undersigned issued an order identifying nine POI cases
On August 28, 2015, Respondent filed a status report in which she stated that she did not intend to contest the undersigned's preliminary findings in any of the presumptively timely cases filed by Mr. Krueger. Resp't's Status Report (Aug. 28, 2015) at 1, ECF No. 84. In status reports filed on September 2 and 30, 2015, Petitioner argued that all of the preliminarily precluded cases were, in fact, timely. See Pet'r's Status Report (Sept. 2, 2015) at 2-7, ECF No. 85 (addressing Culligan, Chenowith, Garner, Lee, Lydia McSherry, and Madelyne Meylor); Pet'r's Status Report (Sept. 30, 2015) at 1-2, ECF No. 87 (addressing Fishkis, Meghan McSherry, Stone).
At a status conference held on October 13, 2015, the undersigned "informed the parties that, for purposes of an onset determination, the [POI] cases [would] be divided [into] two groups: petitioners who never menstruated . . . and the rest of the [POI] petitioners." See Scheduling Order (Oct. 14, 2015) at 1, ECF No. 88.
Relevant post-hearing briefing
Section 300aa-16(a)(2) of the Vaccine Act provides that, regarding
42 U.S.C. § 300aa-16(a)(2).
This statute of limitations is not triggered by the administration of the vaccine, but "begins to run on the date of occurrence of the first symptom or manifestation of onset of the vaccine-related injury for which compensation is sought." Cloer, 654 F.3d at 1335. "[E]ither a `symptom' or a `manifestation of onset' can trigger the running of the statute [of limitations], whichever is first." Markovich v. Sec'y of HHS, 477 F.3d 1353, 1357 (Fed. Cir. 2007).
"[I]t is the first symptom or manifestation of an alleged vaccine injury, not first date when diagnosis would be possible, that triggers the statute of limitations." Carson ex rel. Carson v. Sec'y of HHS, 727 F.3d 1365, 1369 (Fed. Cir. 2013), reh'g & reh'g en banc denied, 2013 WL 4528833 at *1. "A symptom may be indicative of a variety of conditions or ailments, and it may be difficult for lay persons to appreciate the medical significance of a symptom with regard to a particular injury." Markovich, 477 F.3d at 1357. While the symptom of an injury must be recognized as such "by the medical profession at large," Cloer, 654 F.3d at 1335, even subtle symptoms that a petitioner would recognize "`only with the benefit of hindsight, after a doctor makes a definitive diagnosis of injury,'" trigger the running of the statute of limitations, whether or not the petitioner or even multiple medical providers understood their significance at the time. Carson, 727 F.3d at 1369-70 (quoting Markovich, 477 F.3d at 1358).
There is no explicit or implied discovery rule under the Vaccine Act. Cloer, 654 F.3d at 1337. The date of the occurrence of the first symptom or manifestation of onset of the alleged vaccine-related injury "does not depend on when a petitioner knew or reasonably should have known anything adverse about her condition." Id. at 1339. Nor does it depend on when a petitioner knew or should have known of a potential connection between an injury and a vaccine. Id. at 1338 ("Congress made the deliberate choice to trigger the Vaccine Act statute of limitations from the date of occurrence of the first symptom or manifestation of the injury for which relief is sought, an event that does not depend on the knowledge of a petitioner as to the cause of an injury."); see Markovich, 477 F.3d at 1358 ("Congress intended the limitation period to commence to run prior to the time a petitioner has actual knowledge that the vaccine recipient suffered from an injury that could result in a viable cause of action under the Vaccine Act." (internal quotation marks omitted)).
Primary ovarian insufficiency can begin abruptly, see Tr. at 69; see also Nelson at 2-3; but it may also develop over several years, see Tr. at 70, 198-99, 398; see also Nelson at 2-3; Pet'r's Ex. 17, Tab 50 at 2 (Paolo Beck-Peccaz & Luca Persam, Premature Ovarian Failure, 1 Orphanet J. Rare Diseases, at 2 (Apr. 2006) (hereinafter "Beck-Peccaz")). Thus, a woman could have symptoms of POI for several years before actually ceasing menstruation or being diagnosed with POI. See Tr. at 70, 198-99, 398; see also Tr. at 319; Nelson at 2-3; Beck-Peccaz at 2. The experts agreed that the symptoms of POI include menstrual irregularities, including primary and secondary amenorrhea,
By instead finding that "normal" menstrual irregularity is a symptom for purposes of the Act's statute of limitations, Petitioner argues, the undersigned will somehow increase Petitioner's burden of proof. See Pet'r's Post Hr'g Reply Br. at 1-2. The undersigned does not agree. The undersigned does agree, however, that to qualify as the first symptom or manifestation of onset under the Act, a condition must be a symptom of something amiss, however subtle; it cannot be "normal": a symptom is "[a]ny morbid phenomenon or departure from the normal in structure, function, or sensation, experienced by the patient and indicative of disease." Symptom, Stedman's Medical Dictionary (28th Ed. 2013) (hereinafter "Stedman's") (emphasis added); accord Markovich, 477 F.3d at 1360 (observing that eye blinking episodes constituting first symptom of child's seizure disorder "were not normal child behavior"). In order to determine the date of the first symptom or manifestation of onset of the vaccine-related injury, therefore, a method for separating "normal" menstrual irregularities from abnormal symptoms of POI is necessary.
Fortunately, medical literature provided by the parties provides a solution, both simple and elegant. See Resp't's Ex. A.2, ECF No. 57-4 (Comm. on Adolescent Health Care, Am. Coll. of Obstetricians & Gynecologists, Menstruation in Girls and Adolescents: Using the Menstrual Cycle as a Vital Sign, Comm. Op. No. 349 (Nov. 2006)) (hereinafter "ACOG Opinion" or "ACOG Op."); see also Pet'r's Ex. 15, Tab 4. In Cloer and Markovich, the Federal Circuit directed that "the symptom or manifestation of onset must be recognized as such by the medical profession at large." Cloer, 654 F.3d at 1335; Markovich, 477 F.3d at 1360. The ACOG Opinion is an opinion from the Committee on Adolescent Healthcare at the American College of Obstetricians and Gynecologists, together with the American Academy of Pediatrics, entitled "Menstruation in Girls and Adolescents: Using the Menstrual Cycle as a Vital Sign." See ACOG Op. It was issued in November 2006, and "Reaffirmed" in 2009. ACOG Op. at 1. The abstract of the ACOG Opinion provides:
Id. The article goes on to discuss a number of articles and robust epidemiological studies concerning what constitutes "normal menstrual cycles in young females," including age at menarche, and "cycle length and ovulation," id. at 2-3; "abnormal menstrual cycles," including "prolonged interval[s]," id. at 3-4; and "excessive menstrual flow," id. at 4. The article concludes with a chart, reproduced below, that together with one difference applicable to women older than 18, provides comprehensive guidance to the "medical profession at large" about when menstrual irregularities have exceeded "normal" variation to become symptoms of a potential problem. Id. at 4-5. The chart is as follows:
Menstrual periods that:
Id. at 5.
Hillard reproduces this chart, accompanied with this caution:
Hillard at 8 (emphasis added). The ACOG criteria and chart were also translated into lay person's terms and posted for public access on the Womenshealth.gov website. See Pet'r's Ex. 20.
There cannot be a better vehicle for the undersigned to use to sort out "normal" from "symptom" than one designed for that purpose by members of the medical profession themselves. Thus, the undersigned finds that for petitioners who were eighteen years old or younger at the time the condition arose, if the condition qualifies for evaluation on the ACOG chart, it constitutes a symptom for purposes of the Vaccine Act. For petitioners who were over eighteen years old at the time the condition arose, the chart also applies, except that periods that should be evaluated include those that occur more frequently than every 21 days or less frequently than every 35 days. See ACOG Op. at 3.
Finally, as to contraceptives' impact on this analysis, Hillard specifically limited her discussion "only to bleeding on young women who are not taking any hormonal therapy such as birth control." Hillard at 6. All of the experts at the hearing agreed that hormonal therapy would mask POI symptoms. Tr. at 115, 161, 387-88. The ACOG Opinion recommends blood collection for screening before hormonal treatment is begun, ACOG Op. at 4, as did Doctors Hamiel, Tr. at 95-97, and Frankfurter, Tr. at 377, at the hearing; although, both experts acknowledged that such testing is often not performed before hormonal treatment is started. Tr. at 95-97, 112-13, 387-92.
Based on that information, the undersigned makes the following findings regarding how contraceptive use will inform the undersigned's findings concerning the first symptom of POI for purposes of the statute of limitations:
Petitioner filed her petition on April 18, 2014, see Pet.; her petition is therefore time-barred if "the first symptom or manifestation of onset" of her alleged vaccine injury, POI, occurred before April 18, 2011, see 42 U.S.C. § 300aa-16(a)(2). Petitioner asserts that the statute began to run on August of 2012, when she ceased menstruating. Pet'r's Post Hr'g Br. at 2. Respondent asserts that the statute was triggered in March 2010, when Petitioner's menstrual cycle shortened from 28-29 to 25 days. Resp't's Post Hr'g Br. at 3. Alternatively, Respondent asserts that the limitations period dates from late 2010, based on Petitioner's report to her doctor, on May 10, 2011, of six months of less frequent, heavier, and longer menstrual periods, Pet'r's Ex. 2 at 17-18, corroborated by her report, on January 15, 2013, that her oligomenorrhea had begun two years earlier, Pet'r's Ex. 2 at 11-12. Resp't's Post Hr'g Br. at 3.
Petitioner was 26 years old on April 18, 2011. The latest date on which she could have filed her petition without it being barred by the statute of limitations. In 2005 and 2006, her menstrual cycle was regularly 28-29 days. Pet'r's Ex. 6 at 5-7. At that time, she was using a non-hormonal form of contraception, a Paragard (copper) IUD. See Pet'r's Ex. 2 at 8-10; Pet'r's Ex. 6 at 5-6.
The undersigned agrees with Petitioner that the apparent shortening of Petitioner's menstrual cycle to 25 days as of March 31, 2010, see Pet'r's Ex. 2 at 21, did not constitute the first symptom or manifestation of onset of POI, because the 25 day cycle was still within the "normal" parameters for a woman of 25 years—a 21-35 day cycle. However, as of late 2010, Petitioner's menstrual cycle vital sign was not normal pursuant to at least two and possibly as many as four of the ACOG Opinion's criteria:
Thus, as of November or December 2010, Petitioner's menstrual pattern was no longer "normal," but had become symptomatic of potential "disease or derangements in normal health." See Hillard at 8; see also Tr. at 67-68 (documenting Dr. Hamiel's testimony that that she would probably do a work-up on a woman who had regular periods (21-35 days) and then became more irregular (more than every 35 days)). The undersigned finds that this development of menstrual irregularity constituted the first symptom of Petitioner's alleged vaccine-caused injury, POI.
Based on the foregoing analysis, the undersigned finds that the first symptom of Petitioner's injury was November or December 2010. Because that date precedes the statute of limitations deadline by five to six months, the undersigned concludes that Petitioner's claim is time-barred. Her petition therefore must be, and is hereby,
In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court is directed to enter judgment herewith.
